Search results for " sourcing" in Articles / App Notes
Article
EMA Invites Comments on New Guidance for Vaccine Development
The European Medicines Agency (EMA) has released the second module of a new guideline on influenza vaccines for a six-month public consultation. The guidance covers the non-clinical and clinical req…
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Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …
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Bureaucratic Roadblocks Threaten Biopharma Growth
Protecting intellectual property rights is vital to biopharmaceutical innovation.
There is a clear link between a country’s rate of economic development and the strength of its intellectual p…
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Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
The author applies the continuum of criticality to develop the process control strategy and move through Stages 2 and 3 of the new process validation lifecycle.
With the most recent FDA …
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
In a new report on the global biosimilar drugs market, Biosimilars: Parsing the Industry's Pipelines, Moody's Investors Service reports that while biosimilar products have been launched in Asia and …
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Climate Change in Outsourcing
As 2013 draws to a close, the bio/pharmaceutical industry continues to be reshaped by changes in the business climate. Financial, political, and scientific developments that began 10 years ago conti…
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Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.
With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …